Four sites in South Florida are recruiting subjects for a national clinical trial looking at a drug that can potentially slow the process of Alzheimer’s Disease. Researchers hope that this investigational medicine, geared for people with mild to moderate Alzheimer’s who are already being treated with another drug, may modify the pace of a disease that wreaks havoc with the lives of both sufferers and their families.
“Anything we can do to interfere, slow down or stop Alzheimer’s in its tracks is important,” said Dr. Clinton Wright, scientific director of the Evelyn F. McKnight Brain Institute at the University of Miami Miller School of Medicine. “This disease affects a sizable percentage of the population and has potential to affect many more people.”
In addition to the University of Miami, the NOBLE study is also underway at Mount Sinai’s Wein Center for Alzheimer’s Disease and Memory Disorders, the Segal Institute for Clinical Research and Infinity Clinical Research. About 50 sites, with more than 400 patients, are expected to participate in the Phase 2 trail of T-817MA.
Alzheimer’s affects more than 5 million Americans and is the third-leading cause of death in the U.S. As investigators have identified the hallmarks of the disease — amyloid deposits and neurofibrillary tangles — prevention has been at the forefront of medical research. The T-817MA trial, however, takes a different approach. It targets patients between 55 to 85 years old who already have AD. Local scientists say a drug for those in the more advanced stages is desperately needed.
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“There’s a real opportunity to help these people,” said Dr. Harvey Schwartz, a neurologist at Infinity Clinical Research in Hollywood. “I’m not overwhelmed with what’s out there [in treatment], but this trial will give us a chance to see what are the possibilities of improvement.”
The NOBLE study is conducted by the Alzheimer’s Disease Cooperative Study, the largest AD therapeutic research consortium in the country. ADCS tries to support research into drugs that may not get the financial backing of large pharmaceutical companies.
Researchers say there has long been a need for more and better therapies to attack Alzheimer’s. No new drug has been approved by the FDA since 2003 and the ones currently on the market fall into two types: cholinesterase inhibitors and memantine. Both kinds treat symptoms, but nothing has been found to prevent or slow AD’s progress. “What we have now is only for short-term improvement,” Schwartz said, “and we all know this disease is not a short-term thing.”
During this part of the clinical trial, the second of four phases on the journey to possible approval from the U.S. Food and Drug Administration, researchers are looking mainly at the safety of the medication when tested on more participants. “Efficacy,” said Dr. Ranjan Duara, the Wein Center’s medical director, “is important at this phase but the main goal is to assess whether there are any major problems before they ramp up with more participants.”
T-817MA, made by Toyama Chemical Co., works as a neuroprotectant. “It blocks the toxic effect of beta amyloid and tau proteins and is also designed to increase the growth of nerve cells,” Duara said. In other words it protects brain cells from damage and may also create more connections between those cells, making patients more resistant to the disease. Neuroprotectans are already used for many central nervous system disorders, including strokes and Parkinson’s.
During the 14-month trail, participants at the different U.S. sites have a 67 percent chance of receiving the drug, while the others will receive a placebo. Though T-817MA has shown a potential to moderate the progress of the disease, scientists warn it’s still too early to predict outcomes. Even if all goes well, it would be at least five years before the drug would be available on the market.
For more information on the NOBLE study, visit www.NOBLEstudy.org.
You can also contact the local investigative sites:
University of Miami Miller School of Medicine
Contact: Carolina Mendoza-Puccini
Wien Center for Clinical Research
Contact: Adriana Bohorquez
Phone: 305-674-2121, ext. 55099
Segal Institute for Clinical Research
Contact: Maryan Negron
Infinity Clinical Research, LLC
Contact: Jorge Riveros